ID

42538

Descrizione

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. The vaccine administration form should be completed at every vaccination visit (visits 2, 4, and 5 for vaccine doses 1, 2, and 3 respectively). If any adverse events occurred during the immediate post-vaccination time (60 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report with the immediate post-vaccination observation. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section. Please note that informed consent has to be obtained prior to any study procedure.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

versioni (1)
  1. 24/08/21 24/08/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

24 agosto 2021

DOI

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Licenza

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Inglese

Vaccine Administration

1 moduli  
  1. StudyEvent: ODM
    1. Vaccine Administration
Administrative Documentation
Descrizione

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Visit number
Descrizione

Visit number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Vaccine Administration
Descrizione

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date
Descrizione

Fill in only if different from visit date.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-vaccination temperature
Descrizione

Body temperature before vaccination

Tipo di dati

float

Unità di misura
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Pre-vaccination temperature route
Descrizione

Please consider axillary measurement [A] to be the preferable route.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449687
Vaccine administration
Descrizione

Only one box must be ticked by vaccine. If replacement vial [R], please specify the replacement vial number below. If wrong vial number [W], please specify the wrong number below. If not administered [N], please fill reasons in the next item group.

Tipo di dati

text

Alias
UMLS CUI [1]
C2368628
If replacement vial [R], please specify the replacement vial identifier.
Descrizione

Vaccine administration vial device replacement identifier

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
If wrong vial number [W], please specify the wrong identifier.
Descrizione

Vaccine administration vial device wrong identifier

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Has the study vaccine been administered according to the Protocol?
Descrizione

Side / site / route according to protocol: Left / Deltoid / I.M.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If not administered according to protocol, please tick side that applies.
Descrizione

Side drug administration of vaccine

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C2368628
If not administered according to protocol, please tick anatomic site that applies.
Descrizione

Anatomic site administration of vaccine

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
If not administered according to protocol, please tick route that applies.
Descrizione

Route administration of vaccine

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0449444
UMLS CUI [1,2]
C2368628
Vaccine Administration
Descrizione

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Why not administered? Please tick the major reason for non-administration
Descrizione

Non-administration of vaccine primary reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205225
If serious adverse event [SAE], please specify SAE No.
Descrizione

If serious adverse event [SAE], please also complete and submit SAE report.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify AE No.
Descrizione

OR specify solicited adverse event code in the following item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify solicited AE code.
Descrizione

OR specify non-serious adverse event number in the previous item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C1521902
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
Descrizione

Non-administration of vaccine other reason to specify | consent withdrawal | protocol violation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
UMLS CUI [2]
C1707492
UMLS CUI [3]
C1709750
Please tick who made the decision.
Descrizione

Non-administration decision maker

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0679006
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Similar models

Vaccine Administration

1 moduli
  1. StudyEvent: ODM
    1. Vaccine Administration
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
visit 2 (dose 1) (2)
(Comment:en)
CL Item
visit 4 (dose 2) (4)
(Comment:en)
CL Item
visit 5 (dose 3) (5)
(Comment:en)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Body temperature before vaccination
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Pre-vaccination temperature route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Route Body temperature
Code List
Pre-vaccination temperature route
CL Item
Axillary (preferably) ([A])
CL Item
Oral ([O])
CL Item
Rectal ([R])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
RTS,S/AS01E Vaccine or RTS,S/AS02D Vaccine ([S])
CL Item
Replacement vial ([R])
CL Item
Wrong vial number ([W])
CL Item
Not administered ([N])
Vaccine administration vial device replacement identifier
Item
If replacement vial [R], please specify the replacement vial identifier.
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Vaccine administration vial device wrong identifier
Item
If wrong vial number [W], please specify the wrong identifier.
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine according to study protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If not administered according to protocol, please tick side that applies.
text
C0441987 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick side that applies.
CL Item
Left ([L])
CL Item
Right ([R])
Item
If not administered according to protocol, please tick anatomic site that applies.
text
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick anatomic site that applies.
CL Item
Deltoid ([1])
CL Item
Thigh ([3])
CL Item
Buttock ([6])
Item
If not administered according to protocol, please tick route that applies.
text
C0449444 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick route that applies.
CL Item
intramuscular ([IM])
CL Item
subcutaneous ([SC])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Why not administered? Please tick the major reason for non-administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
No administration of vaccine primary reason
Code List
Why not administered? Please tick the major reason for non-administration
CL Item
Serious adverse event ([SAE])
CL Item
Non-serious adverse event ([AEX])
CL Item
Other ([OTH])
Serious adverse event number to specify
Item
If serious adverse event [SAE], please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Non-serious adverse event number to specify
Item
If non-serious adverse event [AEX], please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
If non-serious adverse event [AEX], please specify solicited AE code.
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Solicited adverse event code to specify
Code List
If non-serious adverse event [AEX], please specify solicited AE code.
CL Item
Fever ([FE])
CL Item
Irritability/Fussiness ([IR])
CL Item
Drowsiness ([DR])
CL Item
Loss of appetite ([LO])
Non-administration of vaccine other reason to specify | consent withdrawal | protocol violation
Item
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C1707492 (UMLS CUI [2])
C1709750 (UMLS CUI [3])
Item
Please tick who made the decision.
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Non-administration decision maker
Code List
Please tick who made the decision.
CL Item
Investigator  ([I])
CL Item
Parents/Guardians ([P])
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